Effect of D-amphetamine on Reward Functioning

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Anhedonia

Treatments: Drug: 20mg d-amphetamine; Drug: 10 mg d-amphetamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03369015

HSC-MS-17-0604

Details and patient eligibility

About

The purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related decision-making.

Enrollment: 68 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals

Exclusion criteria

• Individuals with a body mass index (BMI) <19 or >26, as this alters dosing requirements
• Individuals with high blood pressure, abnormal Electrocardiography (EKG), any medical condition requiring regular medication (except birth control), any other regular use of a drug or supplement with potentially hazardous interactions with d-amphetamine (e.g. St. John's wort), or any other medical contraindication to amphetamine administration as determined by our study physician
• Individuals who report no prior experience with recreational drugs of any kind (including alcohol), or who report a previous adverse reaction to amphetamine
• Individuals with a current Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) Axis I diagnosis, excluding mild Substance Use Disorders (≤ 3 symptoms)
• Individuals with a lifetime history of moderate to severe Substance Use Disorder (≥ 4 symptoms), mania or psychosis.
• Women who are pregnant.
• individuals smoking more than 10 cigarettes per week will also be excluded, to avoid confounding the effects of nicotine withdrawal with the effects of the study drugs/procedures, as participants will not be allowed to smoke during the sessions.
• individuals with less than a high-school level of education or fluency in English will be excluded as our questionnaires require high-school level fluency in English, and have not been translated and validated in other languages.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 6 patient groups

Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine

Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine

10 mg d-amphetamine, then placebo, then 20mg d-amphetamine

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine

10 mg d-amphetamine, then 20mg d-amphetamine, then placebo

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine

20 mg d-amphetamine, then 10mg d-amphetamine, then placebo

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine

20 mg d-amphetamine, then placebo, then 10mg d-amphetamine

Experimental group

Treatment:

Drug: Placebo

Drug: 20mg d-amphetamine

Drug: 10 mg d-amphetamine